Independent Analysis Says St.Jude’s Optim-Insulated Defib Leads Show Very Low Insulation Failure Rates

St. Jude Medical, Inc. is no doubt breathing a collective significant sigh of relief at the news that independent academic health research organisation the Population Health Research Institute (PHRI) has given a thumbs up to  the company’s Durata™ and Riata™ ST Optim implantable cardioverter defibrillator (ICD) leads. PHRI found very low rates of insulation abrasion and mechanical failure in its analysis of data received from ongoing prospective registries that monitor the performance of the leads.

The results were presented during the late-breaking clinical trial presentations at Heart Rhythm 2013, the Heart Rhythm Society’s 34th Annual Scientific Sessions, which took place last week in Denver.

Background

PHRI convened a committee of independent physicians chaired by Dr. John Cairns, an internationally recognized expert in cardiology clinical trials who has no affiliations with the cardiac rhythm management device industry, to perform the analysis.

The data came from three actively monitored registries; the OPTIMUM, SCORE and SJ4 Post-Approval registries, all sponsored by St. Jude Medical. The combined data from these registries currently represents more than 11,000 leads implanted at 293 sites.

The findings from PHRI’s initial analysis of the combined Optim-insulated lead registries, for data collected through Feb. 28, 2013, include 99.9 percent rate of freedom from all-cause insulation abrasion (includes all types of abrasion and other mechanical types of insulation damage) at five years.

Furthermore data showed a 99.4 percent rate of freedom from all-cause mechanical failure (includes any insulation abrasion, conductor fracture, failure of a crimp, weld, or bond, or other mechanical failure) at five years.

Physician comments

“Data from St. Jude Medical’s prospective, actively-monitored Optim lead registries have been thoroughly analyzed by PHRI and continue to demonstrate very low rates of insulation abrasion and mechanical failure,” said Dr. John Cairns, professor of Medicine and former dean of Medicine at University of British Columbia in Vancouver. “These prospective registries are well designed with pre-specified definitions for adverse events and a centralized reporting structure. They have now been independently adjudicated by PHRI.”

Company comments

“St. Jude Medical is proud to sponsor the largest actively monitored lead performance evaluation ever conducted for an ICD lead family,” said Dr. Mark Carlson, chief medical officer and senior vice president of Research and Clinical Affairs for St. Jude Medical’s Implantable Electronic Systems Division. “We are pleased that PHRI’s independent analysis of our Optim-insulated lead registries continues to demonstrate the excellent safety and reliability of our Durata ICD leads.”

Source: St.Jude Medical, Inc., Business Wire